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Frequently Asked Questions

Answers to the most frequently asked questions about Cardio Flow’s FreedomFlow® orbital atherectomy system.

What is an atherectomy?

An atherectomy is a medical procedure to remove the build-up of plaque on the walls of an artery, which can reduce or block blood flow to a limb or organ. It is usually performed by inserting a catheter into the vessel and using a special device to cut, scrape, or grind the blockage away.

What is an orbital atherectomy system?

Orbital atherectomy refers to a method physicians may use in removing plaque from an artery. There are five types of atherectomy devices currently on the market. Each uses a different approach:

  • Directional atherectomy devices use a shaving technique to cut and remove plaque.
  • Rotational atherectomy devices use a rotating blade or diamond-coated burr on the tip of the device to cut or sand plaque away.
  • Orbital atherectomy devices use a diamond-coated sanding element that is attached to the side of the device; the element is then rotated in an orbital (eccentric) technique that enables it to adjust to the size of the vessel being treated.
  • Laser atherectomy devices use light energy to vaporize plaque.
  • Intravascular lithotripsy devices use sonic pressure waves to break up plaque.

What do "orbital" and "circumferential" mean?

Cardio Flow’s FreedomFlow® is an orbital circumferential atherectomy system.

“Orbital” refers to the fact that FreedomFlow’s  diamond-coated spheres travel in a circular manner when rotated—the faster the spheres are rotated, the larger the orbit, which enables FreedomFlow to potentially treat arteries of different diameters.

“Circumferential” refers to how the spheres make contact with the artery wall. FreedomFlow’s sphere technology provides multiple, simultaneous contact in several directions during orbital motion, not just on one side of the rotating element. This potentially allows physicians to treat medial calcium—or calcium within the wall of the artery—in addition to calcium present in the artery lumen.

What conditions will FreedomFlow treat?

Cardio Flow is developing a new orbital atherectomy device—the FreedomFlow® Orbital Atherectomy System—that will provide physicians with a way to remove or modify all types of blockages—including calcified and fibrotic plaque—in a wide range of vessel diameters.

FreedomFlow is being developed for use in treating peripheral artery disease and critical limb ischemia—and could eventually be used for treating coronary artery disease and carotid artery disease.

When will FreedomFlow be available on the market?

Cardio Flow has completed the FAST II clinical trial of its FreedomFlow® Orbital Atherectomy System as of Q1 2021. See Development Plan Milestones.

Who is developing this new technology?

Cardio Flow, Inc. is an innovative development company governed by a board of directors with extensive experience in finance and medical device development.

A team of medical device engineers is developing Cardio Flow’s new FreedomFlow® Orbital Atherectomy System.

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